Cromolyn Sodium eentPronunciation
Class: Antiallergic Agents
VA Class: RE100
CAS Number: 15826-37-6
Brands: Crolom, Nasalcrom
Mast-cell stabilizer.208 215 b
Uses for Cromolyn Sodium
Self-medication for the symptomatic prevention and treatment of seasonal or perennial allergic rhinitis.204 Provides symptomatic relief of rhinorrhea, nasal congestion, sneezing, and postnasal drip.a
Allergic Ocular Disorders
Symptomatic treatment of certain allergic ocular disorders (e.g., vernal keratoconjunctivitis,205 208 213 vernal conjunctivitis,205 208 213 vernal keratitis).205 208 213 b
Has been used for the treatment of giant papillary conjunctivitis†.207
Cromolyn Sodium Dosage and Administration
For patients with seasonal or perennial rhinitis, continue therapy throughout the period of allergen exposure (e.g., until the pollen season is over or contact with allergen has ceased).215
If exposure to allergens cannot be predicted, initiate therapy at the first sign of nasal symptoms.215
Should not use other ocular agents with ophthalmic solution unless directed by a clinician.206 209 216 However, may use corticosteroids with ophthalmic solution.205
Administer intranasally or topically to the eye.204 205 206
Administer at regular intervals.204 205 206
Parents or care providers must supervise use by young children.204 In very young children, an adult should administer nasal solution.215 Use care when inserting the nozzle into the nose to avoid injury.215
Prior to administration, clear nasal passages by blowing the nose;215 administration of a topical nasal decongestant may be necessary.a Inhale through the nose during administration.215
For maximum therapeutic effect, initiate therapy before (e.g., ≤1–2 weeks before) and continue at regular intervals during the period of allergen exposure.204 215
Applied topically to the eye as an ophthalmic solution just inside the lower eyelid; patients should avoid applying the solution directly on the cornea.205 206 209 216
To avoid contamination of dropper tip and solution, avoid touching the tip of the dispensing dropper or container to the eye, fingers, or any other surface.206 209 216
Available as cromolyn sodium.204 205
Nasal pump delivers 5.2 mg of cromolyn sodium per metered spray.204
One drop of cromolyn sodium ophthalmic solution contains approximately 1.6 mg of cromolyn sodium.205 b
Children ≥2 years of age: 1 spray (5.2 mg) in each nostril 3 or 4 times daily given at regular intervals (morning, noon, dinner, bedtime)215 for ≤12 weeks.204 215 When necessary, may be used up to 6 times daily.204 215
Allergic Ocular Disorders
Children ≥4 years of age: 1 or 2 drops in each eye 4–6 times daily at regular intervals.205 208 213 b
Do not exceed recommended frequency of administration.205 208 213 b
1 spray (5.2 mg) in each nostril 3 or 4 times daily (morning, noon, dinner, bedtime)215 for ≤12 weeks.204 215 When necessary, may be used up to 6 times daily.204 215
Allergic Ocular Disorders
1 or 2 drops in each eye 4–6 times daily at regular intervals.205 208 213 b
Cautions for Cromolyn Sodium
Known hypersensitivity to cromolyn sodium or any ingredient in the formulations.204 205 213
Ophthalmic solution: Transient stinging or burning sensation may occur.205 208 213 b
Nasal solution: Transient nasal stinging and/or sneezing may occur immediately.204 215 Discontinue drug if nasal irritation occurs.215
Category B.205 208 213 b
Not known whether cromolyn is distributed into milk.205 b Use ophthalmic solution with caution.205 208 213 b With nasal spray, consult a clinician prior to use.204
Safety and efficacy of cromolyn sodium given as the nasal solution204 or ophthalmic solution205 213 b not established in children <2 or <4 years of age, respectively.
Ophthalmic solution: No differences in safety or efficacy relative to younger adults.208 213
Common Adverse Effects
Nasal solution: Nasal burning and stinging, nasal irritation, sneezing.204 215 a
Ophthalmic solution: Transient ocular stinging or burning upon instillation.205 208 213
Cromolyn Sodium Pharmacokinetics
Approximately <7 or 0.03% absorbed following an intranasal dosea or an ophthalmic dose, respectively.205 213 b
Nasal solution: Improvement may take several days; best effect not seen for 1–2 weeks.204 215
Ophthalmic solution: Improvement usually noted in a few days; treatment for up to 6 weeks sometimes needed to see improvement.205 208 213 b
Does not cross most biologic membranes well.a
Minimally crosses the placenta (<0.1%) and minimally distributed into milk (<0.001% of a dose) in animals.a
20–25°C; protect from light.204 215
20–25°C or 15–30°C, depending on manufacturer; protect from light.205 206 208 209 213 216 b Store in original carton.b
Acts mainly through a local effect on the nasal mucosa or eyes.a 215
Inhibits degranulation of sensitized mast cells that occurs after exposure to specific antigens.205 213 b Inhibits release of mediators of type I allergic reactions, including histamine and cysteinyl leukotrienes (slow-reacting substance of anaphylaxis [SRS-A])214 from sensitized mast cells.3 5 6 10 12 33 205 208 212 213 Inhibits phospholipase A-induced mast cell degranulation and subsequent release of chemical mediators in vitro.205 208 b
No direct antihistamine, anticholinergic, antiserotonin, anti-inflammatory, vasoconstrictor, or corticosteroid-like properties.a b 205 213
Advice to Patients
Importance of providing patient a copy of manufacturer’s patient information.204
Importance of clinicians instructing patients about proper use, including proper administration of the particular dosage form employed.205 208 213
With nasal solution, importance of informing a clinician of symptoms such as fever, discolored nasal discharge, sinus pain, or wheezing prior to use.204
Importance of administration of drug at regular intervals.205 208 213 215 b
Importance of avoiding exposure to allergens.215
Importance of advising patients with seasonal or perennial allergic rhinitis to begin therapy before (e.g., ≤1–2 weeks before), and to continue therapy at regular intervals during, the period of allergen exposure.204 215
With intranasal cromolyn, importance of advising patients with allergic rhinitis to discontinue therapy and consult a clinician if symptoms worsen, new symptoms occur, symptoms do not begin to improve within 2 weeks of treatment initiation, or if treatment is required for longer than >12 weeks.204 215
Importance of discontinuing drug and contacting a clinician if shortness of breath, wheezing, hives or swelling of the mouth or throat, or chest tightness occurs.204 215
Importance of not wearing contact lenses during treatment with cromolyn ophthalmic solution.205 206 208 209 213 216
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.204
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.205
Importance of informing patients of other important precautionary information.205 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
5.2 mg/metered spray*
Cromolyn Sodium Nasal Spray (with benzalkonium chloride 0.01% and edetate disodium 0.1%)
Actavis, Bausch & Lomb, Perrigo
Nasalcrom (with benzalkonium chloride 0.01% and edetate disodium 0.1%)
Crolom (with benzalkonium chloride 0.01% and edetate disodium 0.1%)
Bausch & Lomb
Cromolyn Sodium Ophthalmic Solution (with benzalkonium chloride 0.01% and edetate disodium 0.1%)
Akorn, Alcon, King, Novex, Pacific Pharma
AHFS DI Essentials. © Copyright 2017, Selected Revisions July 1, 2007. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
Only references cited for selected revisions after 1984 are available electronically.
3. Cox JS. Disodium cromoglycate: a specific inhibitor of reaginic antibody-antigen mechanisms. Nature. 1967; 216:1328-9. [PubMed 6080064]
5. Anon. Disodium cromoglycate. Lancet. 1972; 2:1299.
6. Anon. Disodium cromoglycate in allergic respiratory disease. Br Med J. 1972; 2:159-61.
10. Falliers CJ. Cromolyn sodium. J Allergy. 1971; 47:298-305. [PubMed 4104162]
12. Orr TS, Cox JS. Disodium cromoglycate, an inhibitor of mast cell degranulation and histamine release induced by phospholipase A. Nature. 1969; 223: 197. [PubMed 4183038]
33. Sheard P, Blair AM. Disodium cromoglycate activity in three in vitro models of immediate hypersensitivity reaction in the lung.Int Arch Allergy Appl Immunol. 1970; 217-24.
204. Pfizer Consumer Healthcare. Nasalcrom(cromolyn sodium) nasal spray product description. Morris Plains, NJ; 2006.
205. Akorn. Cromolyn sodium ophthalmic solution USP 4% prescribing information. Somerset, NJ; 1999 May.
206. Akorn. Cromolyn sodium ophthalmic solution USP 4% information for the patient. Somerset, NJ; 1999 May.
207. Fisons. Opticrom 4% (cromolyn sodium) ophthalmic solution prescribing information. Bedford, MA; 1985 Nov.
208. Pacific Pharma. Cromolyn sodium ophthalmic solution USP, 4% prescribing information. Irvine, CA; 2004 Sep.
209. Pacific Pharma. Cromolyn sodium ophthalmic solution USP, 4% information for the patient. Irvine, CA; 2004 Sep.
212. National Institutes of Health, National Heart, Lung, and Blood Institute. Global initiative for asthma: global strategy for asthma management and prevention NHLBI/WHO Workshop Report. Bethesda, MD: National Institutes of Health. 2005 Oct. NIH/NHLBI Publication No. 02-3659. Available at: . Accessed Nov 7, 2006.
213. Bausch & Lomb. Crolom (cromolyn sodium) ophthalmic solution USP 4% prescribing information. Tampa, FL; 2004 Jan.
214. Drazen JM, Israel E, O'Byrne PM. Treatment of asthma with drugs modifying the leukotriene pathway. N Engl J Med. 1999; 340:197-206. [PubMed 9895400]
215. Bausch & Lomb. Cromolyn sodium nasal solution USP patient information. Tampa, FL. Undated.
216. Bausch & Lomb. Crolom (cromolyn sodium) ophthalmic solution USP 4% information for the patient. Tampa, FL; 2004 Jan.
a. AHFS drug information 2007. McEvoy GK, ed. Cromolyn Sodium. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2776-2777.
b. King Pharmaceuticals. Cromolyn sodium ophthalmic solution prescribing information. Bristol, TN; 1999 May.
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Other brands: Crolom